US biotech regulatory activities to watch for in 2017

Thursday, January 19, 2017

By Greg Jaffe

There were several significant developments surrounding agricultural biotechnology in the US in 2016, including the National Academy of Sciences’ (NAS) report on genetically engineered (GE) crops, the enactment of a federal law requiring mandatory disclosure of foods and ingredients from GE crops, and revisions to the Coordinated Framework’s explanation of the federal oversight of biotechnology. This coming year should be just as eventful. Below are some federal actions expected in 2017 that will play an important role in discussions surrounding how best to regulate and bring to market products made using modern biotechnologies.

National Academy of Sciences’ Report on Future Biotechnology Products

In early 2016, the NAS established a committee to identify what biotechnology products can be expected in the next 10 years and to provide advice on the scientific capabilities, tools, and expertise that may be needed to regulate those products. Once this report is released in early 2017, it should become a valuable resource to stakeholders debating issues surrounding the next generation of biotechnology products. Also, it will inform the federal government’s internal discussions on how it will regulate biotechnology products that don’t currently fit neatly into the Coordinated Framework, including products of gene-editing techniques such as clustered regularly interspaced short palindromic repeats (CRISPR) and transcription activator-like effector nucleases (TALENs).

Implementation of the National Strategy for Modernizing the Regulatory System for Biotechnology Products

The federal National Strategy document, released in September 2016, sets forth future commitments by the government to improve its oversight of biotechnology products. For example, the three agencies overseeing GE products agreed to decide how they will regulate GE insects in an integrated and coordinated fashion. For gene-edited products, the Environmental Protection Agency committed to specifying its regulatory approach for pesticide products. The Food and Drug Administration committed to identifying how it will address gene-edited animals and released its draft guidance on that subject on Jan. 18, 2017. Also, the National Strategy stated that the United States Department of Agriculture (USDA) continues to review its regulatory program and agreed to propose significant revisions to its oversight of GE crops. Those USDA proposed revisions were published in the Federal Register on Jan. 19, 2017. Each of these federal agency decisions will impact which future products make it to market and whether consumers have confidence in the safety of those products.

Implementation of Federal GMO Disclosure Law

The federal GMO Disclosure Law requires regulations to be promulgated by July 29, 2018, and a study assessing electronic or digital link disclosure within one year of enactment. Stakeholders should expect to see the result of the electronic or digital link disclosure study no later than the end of July 2017. Also, it is likely that the USDA will publish an “advanced notice of proposed rulemaking” in early 2017 to obtain initial comments on issues surrounding the disclosure regulations. While the GMO Disclosure Law requires transparency about the GE content of food products, most details about the disclosures will be specified in the regulations. Thus, it is critical that interested stakeholders participate in all public portions of the regulatory development process.

Finally, in 2017, some Americans will have the opportunity to purchase new genetically engineered products, such as non-browning apples and non-browning, low-acrylamide potatoes. This might also be the year when consumers finally get to eat GE salmon steaks, or mark the first time that genetically engineered mosquitoes are released in the US to decrease Zika virus transmission. Regardless of whether all or only some of the actions mentioned above occur, the coming year will be important in determining the future path for products made with different modern biotechnologies.

Greg Jaffe is the Biotechnology Project director for the Center for Science in the Public Interest.